1285819--3/31/2010--OMEROS

related topics

{product, candidate, development}

{product, liability, claim}

{personnel, key, retain}

{property, intellectual, protect}

{stock, price, share}

{stock, price, operating}

{provision, law, control}

{financial, litigation, operation}

{control, financial, internal}

{regulation, change, law}

{cost, regulation, environmental}

{debt, indebtedness, cash}

We have a history of operating losses and we may not achieve or maintain profitability. We are subject to extensive government regulation, including the requirement of approval before our products may be marketed. If our clinical trials are delayed, we may be unable to develop our product candidates on a timely basis, which will increase our development costs and delay the potential commercialization of our products and the subsequent receipt of revenue from sales, if any. If we are unable to raise additional capital when needed or on acceptable terms, we may be unable to complete the development and commercialization of OMS103HP and our other product candidates, or continue our other preclinical development programs. The terms of our debt facility place restrictions on our operating and financial flexibility and if we raise additional capital through debt financing the terms of any new debt could further restrict our ability to operate our business. Our lead product candidate OMS103HP or future product candidates may never achieve market acceptance even if we obtain regulatory approvals. We rely on third parties to conduct portions of our preclinical research and clinical trials. If these third parties do not perform as contractually required or otherwise expected, we may not be able to obtain regulatory approval for or commercialize our product candidates. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate product revenue. We have no ability to manufacture clinical or commercial supplies of our product candidates and currently intend to rely solely on third parties to manufacture clinical and commercial supplies of all of our product candidates. If the contract manufacturers that we rely on experience difficulties with manufacturing our product candidates or fail FDA inspections, our clinical trials, regulatory submissions and ability to commercialize our product candidates and generate revenue may be significantly delayed. Ingredients necessary to manufacture our PharmacoSurgery product candidates may not be available on commercially reasonable terms, if at all, which may delay the development and commercialization of our product candidates. We may need licenses for active ingredients from third parties so that we can develop and commercialize some products from some of our current preclinical programs, which could increase our development costs and delay our ability to commercialize products. Our ability to pursue the development and commercialization of product candidates from our MASP-2 program depends on the continuation of licenses from third parties. Our ability to pursue the development and commercialization of product candidates from our MASP-2 program could be jeopardized by third-party patent rights. Our ability to pursue the development and commercialization of product candidates from our MASP-2 program depends on third-party antibody developers and manufacturers. Our programs may not produce product candidates that are suitable for clinical trials or that can be successfully commercialized. Because we have a number of development programs and are considering a variety of product candidates, we may expend our limited resources to pursue a particular candidate or candidates and fail to capitalize on candidates or indications that may be more profitable or for which there is a greater likelihood of success. It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection. We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights. We use hazardous materials in our business and must comply with environmental laws and regulations, which can be expensive. The loss of members of our management team could substantially disrupt our business operations. We rely on highly skilled personnel and, if we are unable to retain or motivate key personnel or hire qualified personnel, we may not be able to maintain our operations or grow effectively. Our former chief financial officer has filed a lawsuit against us and our current and former directors, the defense of which may consume our time and resources, harm our reputation and the reputations of our current and former directors, and materially negatively affect our financial position and cause our stock price to decline. As a public company we incur increased costs and demands on management as a result of complying with the laws and regulations affecting public companies, which could affect our operating results. Risks Related to Our Industry Our competitors may develop products that are less expensive, safer or more effective, or which may otherwise diminish or eliminate the commercial success of any potential products that we may commercialize. Our product candidates could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements, or if we experience unanticipated problems with our product candidates, if and when any of them are approved. Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products internationally. If we are unable to obtain adequate reimbursement from governments or third-party payors for any products that we may develop or if we are unable to obtain acceptable prices for those products, they may not be purchased or used and, as a result, our revenue and prospects for profitability could suffer. Product liability claims may damage our reputation and, if insurance proves inadequate, these claims may harm our business. Risks Related to Our Common Stock Our stock price has been and may continue to be volatile, and the value of an investment in our common stock may decline. Future sales of shares by existing shareholders could cause our stock price to decline. Anti-takeover provisions in our charter documents and under Washington law could make an acquisition of us, which may be beneficial to our shareholders, more difficult and prevent attempts by our shareholders to replace or remove our current management.

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1285819--3/31/2010--OMEROS_CORP